KEYNOTE 695: TAVO Phase 2b Melanoma Trial Preliminary Data for SITC November 6, 2018
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1 KEYNOTE 695: TAVO Phase 2b Melanoma Trial Preliminary Data for SITC 2018 November 6,
2 FORWARD-LOOKING STATEMENTS To the extent statements contained in the following presentations are not descriptions of historical facts regarding OncoSec Medical Incorporated, they should be considered forward-looking statements, as described in the Private Securities Litigation Reform Act of 1995, that reflect management s current beliefs and expectations. You can identify forward-looking statements by words such as anticipate, believe, could, estimate, expect, forecast, goal, hope, hypothesis, intend, may, plan, potential, predict, project, should, strategy, will, would, or the negative of those terms, and similar expressions that convey uncertainty of future events or outcomes. Forward-looking statements are not assurances of future performance and include, but are not limited to, statements regarding: (i) the success and timing of our product development activities and clinical trials; (ii) our ability to develop and commercialize our product candidates; (iii) our plans to research, discover, evaluate and develop additional potential product, technology and business candidates and opportunities; (iv) our and our partners ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process; (v) the size and growth potential of the markets for our product candidates, and our ability to serve those markets; (vi) the rate and degree of acceptance of our product candidates; (vii) our ability to attract and retain key scientific or management personnel; (viii) the anticipated timing of clinical data availability; (ix) the anticipated timing of commercial launch of ImmunoPulse IL-12; (x) our ability to meet our milestones; (xi) our expectations regarding our ability to obtain and maintain intellectual property protection; (xii) the level of our corporate expenditures; (xiii) the assessment of our technology by potential corporate partners; and (xiv) the impact of capital market conditions on us. Forward-looking statements are subject to known and unknown factors, risks and uncertainties that may cause actual results to differ materially from those expressed or implied by such forward looking statements. These statements are also subject to a number of material risks and uncertainties that are described in OncoSec s most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as updated by its subsequent filings with the Securities and Exchange Commission. Undue reliance should not be placed on forward-looking statements. We undertake no obligation to publicly update any forward-looking statements, except as required by law. OncoSec s investigational drug and device products have not been approved or cleared by the FDA.
3 KEYNOTE-695 Introduction Immune checkpoint inhibitors have become a mainstay in the treatment of melanoma 1 However, a high unmet medical need remains in metastatic melanoma - Most patients do not respond to immune checkpoint inhibition 2,3 - Attempts to potentiate activity by combining ipilimumab and nivolumab has resulted in significant toxicity 4 There is currently no approved therapy in the salvage setting for immune checkpoint inhibitor-refractory metastatic melanoma patient populations 1 - KOLs consider ~10% response rate clinically meaningful as this is what they could elicit with additional chemotherapy; however, responses achieved with chemotherapy are not durable 5 - Tolerability is an important consideration in this heavily pretreated population 1. NCCN Guidelines. Melanoma. v3.2018; 2. Schachter J, et al. Lancet. 2017;390(10105): ; 3. Weber J, et al. Lancet Oncol ; 17(7): ; 4. Shoushtari et al. JAMA Oncology 2017; 5. OncoSec, data on file. 3
4 Patient Eligibility Criteria WRT FDA Approved Anti-PD-1 Therapy Pathologically documented unresectable melanoma, Stage III/IV, with histological or cytological confirmed diagnosis of unresectable melanoma with progressive locally advanced or metastatic disease All patients must be refractory to anti-pd-1 mabs (pembrolizumab or nivolumab according to their approved label) and must meet all of the following criteria: - Received 4+ doses of anti-pd-1 - Progressive disease after anti-pd-1 mab according to RECIST v1.1 - Documented disease progression 24 weeks of the last dose of anti-pd-1 No intervening therapies permitted in-between anti-pd-1 failure and TAVO/KEYTRUDA combination Prior treatment with an approved BRAF inhibitor if BRAF mutation-positive 4
5 KEYNOTE-695 Preliminary Data Interim data set as of September 1, enrolled, 19 patients treated - 9 patients evaluable for first scan, having completed 12 weeks of treatment Preliminary responses (based on RECIST v1.1) - 2/9 PRs and 1/9 SD (22% BORR and 33% DCR) at initial tumor evaluation (12 weeks of treatment) - Immunological response assessment correlated to observed clinical responses - Tumor responses observed in treated and untreated lesions - Preliminary response rates are strong in this salvage patient population Safety Profile - Nearly all Grade 1 AE s of predominately transient pain/discomfort - One TAVO related Grade 3 SAE of cellulitis was reported and resolved - With over a 150 patients treated with TAVO to date, other than two Grade 3 episode of cellulitis, which resolved completely, TAVO-related AEs have been limited to Grade 1, predominately injection site discomfort/pain Based on the outcome of the study and feedback from FDA, the Company plans to file for accelerated approval by end of 2019 or early
6 KEYNOTE-695: TAVO for Stage III/IV Melanoma Anti-PD-1 IL-12 Stage III/IV Combination Electroporation Study Single Arm Phase 2/3 study Primary outcome: BORR based on RECIST v1.1 Secondary outcomes: DOR, PFS and OS Eligible patients: anti-pd-1 non-responders with stage III/IV melanoma - Received 4+ doses of anti-pd-1 - Progressive disease according to RECIST v1.1 - Documented disease progression 24 weeks of the last dose of anti-pd-1 - No intervening therapies permitted in-between checkpoint failure and TAVO/KEYTRUDIA combination TAVO TAVO TAVO Orphan designation Fast Track Breakthrough status Accelerated pathway Approximately 80 patients Dosing ongoing in ~20 sites (U.S. Australia & Canada) Top, preliminary data at SITC 2018 Complete enrollment by mid-2019 P = Pembrolizumabtreatment Positive outcome may support accelerated filing by end 2019/early
7 KEYNOTE-695 Response Rates for First 9 Patients Who Completed 12 Weeks of Treatment Patient Number Response Rate PR PR SD iupd; isd (SD TL / new NTL) iupd; WDC (PR TL / new NTL) iupd; WDC (SD TL / new NTL) PD PD PD SUMMARY OF RESPONSE 2 PR 1 SD 3 iupd 3 PD PR, partial response; SD, Stable Disease; TL, target lesion; NTL, non-target lesion; PD, Progressive Disease; WDC, Withdrew consent; iupd, immunologic unconfirmed progressive disease. 7
8 Overview Patient # Male 65yrs Stage at screening Stage IVB Metastatic disease in lymph nodes (distant), lung and subcutaneous Medical history hip replacement, thumb infection, enlarged prostate, removal of BCC on the neck Prior surgery on lesion on abdominal wall, dissection left groin, sentinel & right axillary lymph node. No radiotherapy. Prior Systemic therapy Pembrolizumab 150 mg IV for 7 cycles => PD 8
9 Medical History 65 year-old white male with Stage IVB melanoma ( ) Medical History: Melanoma History: February 2014 Diagnosis melanoma Excision of primary lesion right abdominal wall Osteoarthritis with bilateral hip replacements Benign prostatic hyperplasia Basal cell carcinoma Spontaneous pneumothorax September 2016 Local recurrence: Excision right abdominal wall October 2017 Distant recurrence: Excision subcutaneous lesion in left forearm Distant LN, lung metastases February 2018 Disease progression in LN and lungs after 7 cycles Clinical trial OMS-I103 March 2014 Wide local resection right abdominal wall Sentinel LN dissection left groin Pembrolizumab 150 mg IV Q3 wk May 2017 (13 Oct Feb 2018) Local recurrence: Wide 7 cycles excision right abdominal wall Right axillary node dissection IV, intravenous; LN, lymph node; Q3 wk, every 3 weeks. 9
10 Measures and PI ORR Assessment Patient # Cycle 5 (2 TAVO treatments) Target Lesion PR Non target lesion non CR / non PR No new lesions Measures TL1 skin (treated) TL2 skin (treated) TL3 lymph (untreated) Baseline 16mm 25mm 28mm Cycle 5 (~12 wks) 4mm 27mm 6mm 10
11 Clinical Trial Experience and 12-week Response Patient # April 2018: Screening Melanoma, Stage IVB, with subcutaneous lesions, lung and LN involvement ECOG PS: 0 16 April July 2018 Treatment as per protocol Cycle 1 5 IT-tavo-EP: Days 1, 5, 8 every other cycle (each 6 weeks) Pembrolizumab (200 mg IV): Day 1 of each 3-week cycle Adverse events Cycle 1 5 Grade 1 injection site pain Investigator deemed related to process of EP and not to the injected treatment April July July 2018 (cycle 5, day 1): Tumor response at 12 weeks Target lesions: PR* 46.4% decrease in sum of diameters Abscopal effect Non target lesions: non CR/ non PR No new lesions identified * RECIST 1.1 = PR; irecist = ipr Continue treatment as per protocol Longest diameter*, mm TL1 (subcutaneous) TL2 (subcutaneous) TL3 (LN) Sum of TL Baseline weeks *LN is measured per RECIST 1.1 on shortest axis. CR, complete response; ECOG, Eastern Cooperative Oncology Group; EP, electroporation; i, Immune; IT-tavo-EP, intratumoral injection of tavo with electroporation; IV, intravenous; LN, lymph node; PR, partial response; PS, performance status; RECIST, Response Evaluation Criteria in Solid Tumor; tavo, plasmid interleukin-12; TL, target lesion. 11
12 Images of Baseline vs. 12 Week Assessment Lesions Patient # Baseline Placeholder for CT TL3 baseline 12 weeks Lesion #1: No photo available due to the tumor being undetectable post treatment. Placeholder for CT TL3 12 weeks 12
13 CT Images of Baseline vs. 12 Week Assessment Lesions Patient # Pre-Treatment 12 Weeks TL1 TL1 TL3 (untreated) Pre-Treatment 12 Weeks TL2 The untreated lesion is a left hilar node, far away from the treated lesions. 13
14 KEYNOTE-695 Response Rates for First 9 Patients Who Completed 12 Weeks of Treatment Patient Number Response Rate PR PR SD iupd; isd (SD TL / new NTL) iupd; WDC (PR TL / new NTL) iupd; WDC (SD TL / new NTL) PD PD PD SUMMARY OF RESPONSE 2 PR 1 SD 3 iupd 3 PD PR, partial response; SD, Stable Disease; TL, target lesion; NTL, non-target lesion; PD, Progressive Disease; WDC, Withdrew consent; iupd, immunologic unconfirmed progressive disease. 14
15 Overview Patient # Female 71yrs Stage at screening Stage IVB Metastatic disease in lymph nodes (distant), lung and subcutaneous Medical history hypothyroidism, Vaginal prolapse, BCC, SCC Prior surgery on skin excisions, wide excisions. No radiotherapy. Prior Systemic therapy Pembrolizumab 150 mg IV for 9 cycles Ipilimumab & nivolumab 4 cycles Nivolumab 2 cycles => PD 15
16 Medical History 71 Year-old White Female with Stage IVB Melanoma ( ) Medical History: Melanoma History: October 2015 Diagnosis of melanoma Skin excision Hypothyroidism Multiple basal cell carcinomas and squamous cell carcinomas Vaginal prolapse Constipation, insomnia, anxiety, and night sweats Adjuvant Pembrolizumab 2 mg/kg IV Q3 wk (Apr Sep 2017) 9 cycles Ipilimumab 3 mg/kg IV Q3 wk Nivolumab 1 mg/kg IV Q3 wk (23 Oct Dec 2017) 4 cycles May 2017 Distant Recurrence: IVA Nivolumab 3 mg/kg IV Q2 wk (15 Jan Feb 2018) 2 cycles Clinical trial OMS-I103 November 2015 Wide local excision March 2017 Local recurrence: Wide excision of forehead 3 core biopsies IV, intravenous; Q2 wk, every 2 weeks; Q3 wk, every 3 weeks. 16
17 Measures and PI ORR Assessment Patient # Cycle 5 (2 TAVO treatments) Target Lesion PR Non target lesion non CR / non PR No new lesions Measures TL1 skin TL3 skin Baseline 32mm 24mm Cycle 5 (~12 wks) 22mm 17mm 17
18 Clinical Trial Experience and 12-week Response Patient # May 2018: Screening Melanoma, stage IVA, with skin lesions ECOG PS: 0 24 May August 2018 Treatment as per protocol Cycle 1 5 IT-tavo-EP: Days 1, 5, 8 every other cycle (each 6 weeks) Pembrolizumab (200 mg IV): Day 1 of each 3-week cycle Adverse events Cycle 1 5 Grade 1 pruritis: related to pembrolizumab; not related to TAVO or EP Grade 1 night sweats: not related to any of the treatments or EP Grade 2 diarrhea: related to pembrolizumab and TAVO; not related to EP May August August2018 (cycle 5, day 1): Tumor response at 12 weeks Target lesions: PR* 30% decrease in sum of diameters Non target lesions: non-cr/non- PD No new lesions * RECIST 1.1 = PR; irecist = ipr Continue treatment as per protocol Longest diameter, mm TL1 (skin) TL3 (skin) Sum of diameters TL Baseline weeks CR, complete response; ECOG, Eastern Cooperative Oncology Group; EP, electroporation; i, Immune; IT-tavo-EP, intratumoral injection of tavo with electroporation; IV, intravenous; LN, lymph node; NTL, non-target lesion; PR, partial response; PS, performance status; RECIST, Response Evaluation Criteria in Solid Tumor; tavo, plasmid interleukin-12; TL, target lesion. 18
19 Baseline vs. 12 Week Assessment Target and Non-Target Lesion Images ( ) Baseline 12 weeks 19
20 Axial Images Baseline vs. 12 Week Assessment Target and Non-Target Lesion Images ( ) Axial images from patient # showing large exophytic scalp lesions. 20
21 Intratumoral Gene Expression Patient # Intratumoral gene expression in a PR demonstrates increased antigen presentation and T cell activation / trafficking 21
22 Intratumoral Gene Expression Patient # Intratumoral gene expression in a PR demonstrates a treatment-related increase in adaptive resistance 22
23 KEYNOTE-695 Response Rates for First 9 Patients Who Completed 12 Weeks of Treatment Patient Number Response Rate PR PR SD iupd; isd (SD TL / new NTL) iupd; WDC (PR TL / new NTL) iupd; WDC (SD TL / new NTL) PD PD PD SUMMARY OF RESPONSE 2 PR 1 SD 3 iupd 3 PD PR, partial response; SD, Stable Disease; TL, target lesion; NTL, non-target lesion; PD, Progressive Disease; WDC, Withdrew consent; iupd, immunologic unconfirmed progressive disease. 23
24 Overview Patient # year-old white male with stage IVA melanoma 10 cycles of pembro 200 mg Surgery arm for melanoma / axillary clearance / axillary SLNB No radiation therapy 16Jul2018 (cycle 5, day 1): Target lesion: SD (0% decrease in sum of diameters) Non target lesions: non CR / non PD No new lesions TL1 skin TL2 skin Sum of TL Screening 19 mm 11 mm 30 mm Cycle 5 19 mm 11mm 30 mm 24
25 Multispectral IHC Patient # Multispectral IHC: patient has an immuno-active lesion after a single cycle of treatment 25
26 KEYNOTE-695 Response Rates for First 9 Patients Who Completed 12 Weeks of Treatment Patient Number Response Rate PR PR SD iupd; isd (SD TL / new NTL) iupd; WDC (PR TL / new NTL) iupd; WDC (SD TL / new NTL) PD PD PD SUMMARY OF RESPONSE 2 PR 1 SD 3 iupd 3 PD PR, partial response; SD, Stable Disease; TL, target lesion; NTL, non-target lesion; PD, Progressive Disease; WDC, Withdrew consent; iupd, immunologic unconfirmed progressive disease. 26
27 Overview Patient year-old white male with stage IVB melanoma 4 cycles of pembro 210 mg Surgery Lymph node / heel No radiation therapy 16Mar2018 (cycle 5, day 1): Target lesions: Stable Disease (13% decrease in sum of diameters) Non target lesions: non CR / non PD New lesions: yes but isd Patient is still on treatment Baseline 12 weeks TL1 skin Sum of TL Screening 23 mm 23 mm Cycle 5 20 mm 20 mm isd, Immuno-Stable Disease 27
28 KEYNOTE-695 Response Rates for First 9 Patients Who Completed 12 Weeks of Treatment Patient Number Response Rate PR PR SD iupd; isd (SD TL / new NTL) iupd; WDC (PR TL / new NTL) iupd; WDC (SD TL / new NTL) PD PD PD SUMMARY OF RESPONSE 2 PR 1 SD 3 iupd 3 PD PR, partial response; SD, Stable Disease; TL, target lesion; NTL, non-target lesion; PD, Progressive Disease; WDC, Withdrew consent; iupd, immunologic unconfirmed progressive disease. 28
29 Overview Patient # year-old white female with stage IVC melanoma Prior treatments: Temozolmide 4 cycles Nivolumab 18 cycles Ipi 3 cycles Trametinib / IL-2 2 cycles Epadacostst 4 cycles Interferons / pembrolizumab 4 cycles Ipi & nivo 4 cycles Surgery intussusception repair No radiation therapy Patient receive only sub-optimal dose of TAVO due to difficulty in administration Aug 2018 (cycle 5, day 1): Target lesions: SD (<10% decrease in sum of diameters) TL1 skin TL2 TL4 Non target lesions: non CR / non PD Screening 82 mm 28 mm 22 mm New lesions and patient withdrew Cycle 5 pending pending pending 29
30 KEYNOTE-695 Response Rates for First 9 Patients Who Completed 12 Weeks of Treatment Patient Number Response Rate PR PR SD iupd; isd (SD TL / new NTL) iupd; WDC (PR TL / new NTL) iupd; WDC (SD TL / new NTL) PD PD PD SUMMARY OF RESPONSE 2 PR 1 SD 3 iupd 3 PD PR, partial response; SD, Stable Disease; TL, target lesion; NTL, non-target lesion; PD, Progressive Disease; WDC, Withdrew consent; iupd, immunologic unconfirmed progressive disease. 30
31 Overview Patient # year-old white male with stage IVB melanoma Prior treatments: Encorafenib 2 cycles Binimetinib 2 cycles Dabrafenib 30 cycles Trametinib 30 cycles Pembrolizumab 18 cycles [200mg] Surgery scalp No radiation therapy Aug 2018 (cycle 5, day 1): Target lesion: SD (0% decrease in sum of diameters) Non target lesion: NE New lesions Patient withdrew from study TL1 skin TL2 SUM TL Screening 20 mm 14 mm 34 mm Cycle 5 18 mm 15 mm 33mm 31
32 KEYNOTE-695 Response Rates for First 9 Patients Who Completed 12 Weeks of Treatment Patient Number Response Rate PR PR SD iupd; isd (SD TL / new NTL) iupd; WDC (PR TL / new NTL) iupd; WDC (SD TL / new NTL) PD PD PD SUMMARY OF RESPONSE 2 PR 1 SD 3 iupd 3 PD PR, partial response; SD, Stable Disease; TL, target lesion; NTL, non-target lesion; PD, Progressive Disease; WDC, Withdrew consent; iupd, immunologic unconfirmed progressive disease. 32
33 74 year-old white female with stage IIIC melanoma Prior treatment: Pembrolizumab 4 cycles Ipi & nivo 4 cycles Surgery No radiation therapy April 2018 (cycle 5, day 1): Target lesions: PD Non target lesions: PD New lesions No longer on treatment Overview Patient # TL5 skin TL2 TL3 (vaginal mass) Screening 15 mm 69 mm 22 mm EOS 15 mm 84 mm 24 mm 33
34 61 year-old white female with stage IVA melanoma Prior treatment: Pembrolizumab 11 cycles Ipi 4 cycles Nivo 16 cycles Surgery / groin excision / subcut mets No radiation therapy Mar2018 (cycle 5, day 1): Target lesions: SD Non target lesions: non CR / non PD New lesions No longer on treatment Overview Patient # Screening Cycle 5 TL15 skin 13 mm 13 mm 34
35 ORR and Tumor Measures 71 Year-old White Male with Stage IVA Melanoma ( ) Baseline Images Cycle 5 Images TL1 LN TL3 skin SC TL4 skin TL5 skin SC TL9 skin Sum of TL Screening 31mm 71mm 24mm 33mm 39mm 198 Cycle 5 35mm 47mm 11mm 41mm 42mm Jul2018 (cycle 5, day 1): Tumor response at 12 weeks Target lesions: SD 11% decrease in sum of diameters Non target lesions: PD New lesions Patient was found to have a new lytic lesion in the distal femur. The lesion was examined and determined to be high potential for a pathological femoral fracture and patient was electively hospitalized, underwent left femoral intramedullary rod insertion, and could no longer be treated. TL, target lesion; NTL, non-target lesion; SD, stable disease; PS, performance status; iupd, immunologic unconfirmed progressive disease; ORR, overall response rate 35
36 CD3 + /CD8 + /PD- Immunologic Impact via mihc Patient # Screen Tumoral PD C2D1 L mihc Demonstrates a Powerful Treatment-related Increase in TIL Density with 1 Cycle of TAVO /PEMBRO in an Immunologically Cold Lesion 36
37 PRELIMINARY SAFETY 37
38 KEYNOTE-695 TAVO + Pembrolizumab Tolerability in Patients Who Completed 12 Weeks of Treatment TAVO related AEs Pembrolizumab-related AEs Total AEs/SAEs related to study drugs Grade 1, n (%) 5/9 (55.6) 3/9 (33.3) 8/9 (88.9) Grade 3, n (%) 1/9 (11.1) 2/9 (22.2) 3/9 (33.3) TAVO -related AEs were limited to grade 1 injection site discomfort/pain, except for one grade 3 episode of cellulitis, which resolved completely 38
39 ADDITIONAL PRELIMINARY BIOMARKER DATA 39
40 A treatment-related upregulation of immune-based transcripts in the tumor microenvironment was observed in 7 matched biopsies 40
41 IHC: PR Has Increase in the Density of CD8 + TILs PD PR PD SD 41
42 IHC: PR/SD Have Increased PD-L1 + Tumor Cells PR PD PD SD 42
43 gmdsc Reduced in PR/SD Patients Partial Response ( ) Screen C2D 1 Progressive Disease ( ) Screen C2D 1 Stable Disease ( ) Screen C2D 1 Progressive Disease (61-007x-102) Screen C2D 1 43
44 Decreased Monocytes/Macrophages in PR/SD Partial Response ( ) Screen C2D1 Progressive Disease ( ) Screen C2D1 Stable Disease ( ) Screen C2D1 Progressive Disease ( ) Screen C2D1 44
45 Increased Frequency of Peripheral CD8 + T Cells in PR/SD Patients After 1 Cycle of Treatment PR ( ) SD ( ) PD ( ) PD ( ) 45
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